Senior Design Quality Engineer

The role

You will guide design quality from early concept through commercialization and design transfer as a core member of cross-functional product development teams. You will apply expertise in design controls, risk management, and verification and validation for healthcare products.

What you will do

• Build knowledge of quality management system, product development lifecycle, and design-quality practices
• Establish partnerships with hardware, software, systems, product, program management, and Regulatory Affairs stakeholders
• Review requirements, design records, risk documentation, and development plans
• Own design-control and risk-management execution across product development programs
• Create and maintain design history file records
• Develop and review risk-based verification and validation strategies
• Provide quality feedback on design architectures, component selections, requirements, and usability
• Drive quality readiness for design transfer and commercialization
• Lead or support product risk-management activities
• Support Regulatory Affairs with submissions, responses, and audit preparation

Required qualifications

• Bachelor’s degree in electrical engineering, mechanical engineering, systems engineering, mathematics, physics, or a related technical field
• 6+ years of experience in quality engineering or a related field
• At least 4 years in a medical-device design and development environment
• 3+ years of experience applying design controls and risk management from early design through commercialization
• Experience with electromechanical systems
• Experience with ISO 13485, ISO 14971, IEC 60601, IEC 62304, and 21 CFR Part 820

Nice to have

• Advanced degree in engineering, mathematics, physics, or a related technical field
• Experience with software as a medical device (SaMD) and software in a medical device (SiMD)
• Experience navigating a quality management system with minimal oversight
• Ability to make balanced risk decisions and build consensus
• Experience coaching, mentoring, or teaching engineering teams in design quality, data analysis, protocol development, reliability, or design-for-quality methods
• Experience communicating complex quality, technical, and regulatory information to executive management

Benefits

• Medical, dental, and vision coverage
• Gender-affirming care help
• Tools for family and fertility planning
• Travel reimbursements if healthcare is not available where you live
• Traditional or Roth 401(k) retirement plan options with a 2% company match
• Learning and development stipends
• Discounted company stock through ESPP

About the company

Hinge Health uses technology to scale and automate the delivery of healthcare for musculoskeletal (MSK) conditions. The company is headquartered in San Francisco with additional offices in Montreal and Bangalore.